FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68387-690
11-digit product format
683870690
Labeler code
68387
Product ID
68387-690_1df7b178-a093-4436-81da-a213d1b7cdcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA040527
Marketing category
ANDA
Marketing start
2007-07-31
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-690-072019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
68387-690-142019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
68387-690-152019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
68387-690-212019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
68387-690-282019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
68387-690-302019-10-21C16284748780-1956f9ecf-c891-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-690-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET72
68387-690-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET142
68387-690-15Phentermine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET152
68387-690-21Phentermine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET212
68387-690-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET282
68387-690-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-690PHENTERMINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 6 package rows20100624_7a971256-645a-4477-86c7-5033e0e520f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN7a971256-645a-4477-86c7-5033e0e520f62
803353phentermine hydrochloride 37.5 MG Oral TabletSCD7a971256-645a-4477-86c7-5033e0e520f62
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY7a971256-645a-4477-86c7-5033e0e520f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-690-07683870690077 in 1 BOTTLE, PLASTICHistorical
68387-690-146838706901414 in 1 BOTTLE, PLASTICHistorical
68387-690-156838706901515 in 1 BOTTLE, PLASTICHistorical
68387-690-216838706902121 in 1 BOTTLE, PLASTICHistorical
68387-690-286838706902828 in 1 BOTTLE, PLASTICHistorical
68387-690-306838706903030 in 1 BOTTLE, PLASTICHistorical